FDA approves topical treatment for excessive underarm sweating
The U.S. Food and Drug Administration (FDA) has approved topical glycopyrronium (Qbrexza, Dermira) for the treatment of adults and children who have primary axillary hyperhidrosis.
Qbrexza is a topical anticholinergic cloth applied to the underarms and designed to block sweat production by inhibiting sweat gland activation.
The safety and efficacy of Qbrexza for primary axillary hyperhidrosis were evaluated in two phase 3 clinical trials (ATMOS-1 and ATMOS-2). Both trials assessed the level of change from baseline in sweat production after treatment with Qbrexza, along with the proportion of patients who achieved a level of improvement from baseline in sweating severity as measured by the Axillary Sweating Daily Diary (ASDD), Dermira’s proprietary patient-reported outcome (PRO) instrument.
Axillary hyperhidrosis, which affects nearly 10 million people in the United States, can impede normal daily activities and result in occupational, emotional, psychological, social, and physical impairment.
“Primary axillary hyperhidrosis is a condition that has negatively impacted many of my patients for most of their lives,” Dee Anna Glaser, MD, professor and interim chair, Department of Dermatology at Saint Louis University School of Medicine, Missouri, said in the release. “I look forward to Qbrexza’s potential to be a meaningful treatment option that will not only reduce a person’s sweat, but will reduce the overall impact this condition has on their daily life.”
The most common adverse reactions seen in patients treated with Qbrexza were dry mouth (24.2 percent), mydriasis (dilation of the pupils) (6.8 percent), oropharyngeal pain (5.7 percent), and headache (5.0 percent).